Phase 3
N=169
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01055262 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) — 2.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Heatwrap 1 (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) |
2.4 | — |
| SECONDARY Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) |
1.2; 1.2; 2.4; 2.4 | — |
| SECONDARY Time to First Significant Skin Event |
2.0 | — |
| SECONDARY Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) |
3.0; 3.6; 5.3; 6.5; 6.5 | — |
| SECONDARY Time to First Report of Non-zero Erythema Score or Elevated Response |
2.2 | — |
| SECONDARY Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation |
NA | — |
| SECONDARY Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day |
0.6 | — |
| SECONDARY Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day |
0.6 | — |
Summary
The objectives of this study are to evaluate the dermal safety and on-body temperature of a disposable heatwrap product when worn while in a supine position for five consecutive days. The product will be worn on the back for approximately 8 hours per 24 hour period.
Eligibility Criteria
Inclusion Criteria
- The subject is a male or female in generally good health greater or equal to 35 years of age;
- Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device, diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);
- The subject has a waist-hip circumference of between 27-47 inches inclusive.
Exclusion Criteria
- The subject is a pregnant or lactating woman;
- The subject is diabetic;
- The subject has a history of melanoma, squamous or basal cell carcinoma in the area of application of the lower back and hip;
- The subject has any active skin disease which may contraindicate participation, including eczema, rash, broken or irritated skin, contact dermatitis and atopic dermatitis, or any skin condition that may be aggravated by heat;
- The subject has used (within the previous week) or is using any topical drug or heatwrap or electrical heat pads at the application site; or
- The subject has damaged skin in, or around the test sites which includes sunburn, uneven skin tones, tattoos, scars or other disfiguration at the application site, including an erythema grading of greater than 0 at the application site.
Data sourced from ClinicalTrials.gov (NCT01055262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.